Clinical Trials Contracts Lead

A highly skilled Contracts Specialist is required to lead complex projects, negotiate and prepare contracts, budgets, and related documents for participation in industry-sponsored clinical trials.

• Leads multi-country projects including negotiating and preparing contracts, budgets, and related documents.
• Produces site-specific contracts from country clinical trial agreement (CTA) template, reviews, and owns them.
• Negotiates budget and contract with site and sponsor until resolution of issues.
• Performs quality control and arranges execution of CTAs, archival of documents into repositories, and capture of metadata.
• Reviews contracts for completeness and accuracy, ensuring corrections are made and documented.
• Administers all contract management processes, including coordination with relevant protocol, informed consent, institution, investigator, vendor, consultant, and customer agreement documents at a project level.
• Generates amended contract and/or budget documents as necessary, preparing contract management documentation for projects.
• Works closely with Site Contract Service Center and Legal to harmonize site contract to reflect sponsor's master service agreement terms.
• Collaborates with SSU lead, Clinical Operations, and Finance to validate departmental budgets and corresponding backlog.
• Identifies possible contract or process operational risk and proactively works within the team to provide solutions.
• Establishes strong working relationships with SSU lead, customer, and internal project teams. Escalates deviations to department leadership and/or Site Contract Service Center and/or Legal Department.
• Provides support to business development and represents site contracts/Site Start-Up (SSU) at internal or customer meetings.
• Works within forecasted country/site contracting timelines, ensures compliance, and tracks milestone progress in real-time using agreed-upon SSU tracking systems.
• Collaborates with internal and external legal, finance, and clinical operations departments, communicating and explaining legal and budgetary issues.
• Maintains and supports review and development of contract templates, budget templates, and site-specific files and databases.
• Serves as key communication liaison between site contracts staff and internal and external customers.
• Provides functional guidance and keeps internal and external teams aware of all contract statuses or pending issues.
• Prepares correspondence as necessary.

• Bachelor's degree in Business Administration, Public Administration, Public Health, or equivalent combination of education and experience.
• Advanced degree preferred.
• Moderate contracts management experience, including experience in a contract research organization or pharmaceutical industry.
• Management experience preferred.
• Strong knowledge of the clinical development process and legal and contracting parameters.
• Strong computer skills in Microsoft Office Suite.
• Customer-focused and ability to manage challenging priorities and remain flexible and adaptable in stressful situations.
• Excellent understanding of clinical trial process across Phases II-IV and ICH GCP.
• Good understanding of clinical protocols and associated study specifications.
• Excellent understanding of clinical trial start-up processes.
• Project management experience in a fast-paced environment.
• Good vendor management skills.
• Strong organizational skills with proven ability to handle multiple projects.
• Excellent communication, presentation, and interpersonal skills.
• Quality-driven in all managed activities.
• Strong negotiating skills.
• Strong problem-solving skills.
• Ability to mentor and motivate more junior staff.
• Demonstrate an ability to provide quality feedback and guidance to peers.

This is a remote/home-based position open to candidates located anywhere within the United States.

We have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products, and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.